- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00235911
Symbicort Single Inhaler Therapy for Asthma in a General Practice Setting
January 21, 2011 updated by: AstraZeneca
Effects of Symbicort Single Inhaler Therapy on Bronchial Hyper Responsiveness, Asthma Control and Safety in Mild to Moderate Asthmatics in General Practice, Compared to Usual Care Therapy
The primary objective is to compare the effects of Symbicort SiT and treatment according to NHG-guidelines on bronchial hyperresponsiveness in asthmatic patients, as measured by PD20 histamine, and to validate the Bronchial Hyperresponsiveness Questionnaire (BHQ).
Study Overview
Study Type
Interventional
Enrollment
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Appingedam, Netherlands
- Research Site
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Groningen, Netherlands
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosis of mild to moderate asthma, FEV1 ³ 60% of predicted normal values pre-bronchodilator, daily use of inhaled GCS during the last 3 months
Exclusion Criteria:
- Regular need of >4 inhalations of a short-acting b2-agonist/day, known or suspected hypersensitivity to any of the investigational drugs or inhaled lactose, use of any b-blocking agent, having smoked ³10 pack-years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change in PD20 histamine
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Secondary Outcome Measures
Outcome Measure |
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number of asthma-control days, time to first mild asthma exacerbation, number of mild asthma exacerbation days, asthma symptom scores (day and night), FEV1, PEF (morning and evening), Number of inhalations with iGCS and mean dose of iGCS
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Primary Completion (Actual)
October 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
October 7, 2005
First Submitted That Met QC Criteria
October 7, 2005
First Posted (Estimate)
October 12, 2005
Study Record Updates
Last Update Posted (Estimate)
January 24, 2011
Last Update Submitted That Met QC Criteria
January 21, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Budesonide
- Formoterol Fumarate
Other Study ID Numbers
- BN-00S-0011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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